A Study of VET3-TGI in Patients With Solid Tumors (STEALTH-001)

Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
Determine the recommended Phase 2 dose

Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.
Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy
Measurable disease as per RECIST 1.1 criteria
At least one tumor amenable to safe ITu injections and/or biopsies
ECOG performance status 0 or 1
Demonstrate adequate organ function
Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions

Prior systemic therapy washout (dependent upon the therapy)
Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
Prior history of myocarditis
Known HIV/AIDS, active HBV or HCV infection.
Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).

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